1. Field of the Invention
The present invention relates to surgical equipment, and more particularly, to a device for maintaining intravascular access devices, such as needles, tubes, and catheters in fixed position while administering intravascular therapy, wherein the risk of accidental dislodgement of the intravascular access device during the therapy is minimized substantially.
More particularly, the present invention relates to a structure for immovably maintaining an intravascular access device in fixed position on a limb of a patient, with the structure including a needle immobilizing unit and a tube locking member securing a connecting tube of the intra-vascular access device in fixed position to the needle member. The needle immobilizing unit includes a substantially transparent shield covering the needle member that allows immediate visual recognition of any dislodgement of the intra-vascular access device whenever such may occur.
Further, the present invention relates to a hemodialysis and vascular splint which conveniently and comfortably supports intravascular access devices at a patient's extremity for an extended period of time which is required by certain intravascular therapies including hemodialysis. More particularly, the present invention relates to a splint which comprises two independent members assemblable and easily separable each from the other so that each may be used independently or in combination dependent upon the specific procedure.
The present invention also relates to a splint for supporting intravascular device(s) in fixed position which includes one or two separable splint members where each is affixed to a respective body part by at least one strap which is slidable along the splint member and whose length is adjustable. The splint also maintains an intravascular access device (the needle member and the connecting tube) thereon in the locked position thereby preventing unwanted dislodgement of the intravascular access device during therapy.
2. Prior Art
In the field of surgery, intravascular access devices are widely used for many purposes. For example, the vascular access can be venous when fluids, such as medicine or supporting fluids, are desired to be given to a patient undergoing a surgical procedure. In medical emergencies, intravenous access may be needed to administer fluids, antibiotics, and other medication especially when the patient cannot ingest such through the mouth.
Another type of vascular access, arterial access, is needed to monitor the patient's blood gases and may be used for monitoring his or her vital signs. Patients on hemodialysis may need intravascular access two to three times each week for a period of three hours or longer.
If a needle is dislodged in any of these procedures, and the dislodgement goes unnoticed, severe bleeding may occur. In such instances, the patient may lose a large amount of blood before the medical personnel recognizes the emergency situation. In some cases where the patient is heparinized, i.e., blood is prevented from clotting, the patient may bleed to death, unless the bleeding is recognized and stopped. In hemodialysis, the blood loss in such emergency situations could be as high as several hundred millimeters each minute.
In order to impede separation of the connecting tube from a needle of the intravascular access device, traditionally, strips of tape are applied to a patient's limb which secures the connecting tube and the needle in the proper position on the patient's body. Disadvantageously, this technique abrades hair and skin of the patient in the contact areas and in some instances, may cause serious unwanted skin reaction.
Several attempts have been made in the art to develop a technique which would prevent the vascular bleeding when intravascular access is desired. For example, U.S. Pat. No. 5,601,597 describes the combination radial artery occluder and wrist splint used to simultaneously immobilize the wrist joint and prevent blood flow through a puncture wound or incision in the radial artery following an invasive medical procedure, such as catheterization. The device generally includes three components: a wrist splint that extends along the distal end of the patient's forearm and the back of the wrist and hand; an adjustable pressure strap attached to the splint that extends around the distal end of the forearm; and an adjustable securing strap attached to the splint that extends around the palm of the patient's hand. The pressure strap includes a pressure pad that is selectively positioned to occlude blood flow through only the radial artery, while allowing blood flow through the ulnar artery. During use, the securing strap is tightened around the palm of the hand to help immobilize the wrist joint. The adjustable pressure strap is slowly tightened onto the forearm or wrist over the wound until radial artery blood flow has stopped at the wound. Although intended for stopping blood from punctured arteries, this device is not contemplated for use during the intravascular access procedure, and therefore, no means are envisioned for securing an intravascular access device to the patient's limb.
A prior art splint for use with intravenous lines is described in U.S. Pat. Nos. 4,425,913 and 4,502,477. The splint supports the hand, wrist, and at least a portion of the forearm of a patient during the time, when the patient is connected to a lifeline, e.g., intravenous tube. The splint incorporates a substantially rigid molded body defining several shapes. A dome is provided for mating engagement with the palm of the hand and a transversely arcuate curved channel extends away from the dome to receive the wrist and a portion of the forearm. The molded body defines securing means for the lifeline, as in the form of rolled or beaded edges of the body which also add strength and rigidity. The molded body is to be physically attached to a patient by the straps, with a hand strap extending somewhat diagonally in relation to the dome, while a pair of forearm straps extend laterally from the opposed side of the molded body. The length of the straps is adjusted by a Velcro type contact fastening member. In use, after the splint is positioned onto the patient and the molded body is secured in place with the contact straps, the intravenous lifeline is connected with the tube anchored in a channel extending along the edges of the molded body. As is readily understandable for those skilled in the art, this splint is intended merely as a support to immobilize the forearm and hand of the patient during intravenous therapy and also as a support for a lifeline, i.e., connecting tube through which liquid is supplied to a needle or a catheter. Disadvantageously, no means are contemplated which would secure the connecting tube to the needle introduced into the blood vessel.
Therefore, in such prior art, a dangerous, undesirable disconnection of the lifeline from the needle may occur. It is a further drawback of the splint described in the previous paragraphs that it is not designed for use as a support for a needle or catheter inserted into the blood vessel of a limb. As a further disadvantage, it may be recognized that different sizes of the splint are generally desirable to accommodate the physical dimensions of different patients, as well as different dimensional needs for the right and the left limbs of the same patient which may require different splints.
A fluid administration splint is also described in U.S. Pat. No. 4,505,270. This splint is intended as a shield for a catheter taped to the leg of an animal. The splint includes an extendable splint member hinged to an extendable cover for accommodating different lengths of a leg, and a latch for securing the splint assembly to a door of a cage containing the animal receiving intravenous fluid. Similar to the splint described in previous paragraphs, the fluid administration splint shown in this prior art is merely a support to immobilize the limb during intravenous therapy.
As it is readily appreciated by those skilled in the art, none of the splints discussed in the previous paragraphs contemplates any means which would secure the needle or a catheter, immovably with respect to its connecting tube during the intravascular access therapy. Further, none of them are intended for use with the arm part, forearm part, and/or the hand of the patient, in combination or individually.
Therefore, despite numerous attempts in the field of surgery to provide means or technique which would reliably secure the intravascular access device in position, no satisfactory technique has been developed to date prior to the subject system.